A Randomised Trial of S-ICD Implantation With and Without Defibrillation Testing
This study is investigating a heart device called a subcutaneous implantable cardioverter defibrillator (S-ICD) for people with dangerous abnormal heart rhythms. Currently, when these devices are put in, doctors often do a 'defibrillation test' to make sure it works correctly. However, this test can sometimes lead to complications. This research aims to find out if it's just as safe and effective to implant the S-ICD without performing this test, especially if we use a special scoring system called PRAETORIAN to help check the device's position. If successful, this could mean fewer risks and a smoother procedure for patients needing this life-saving device in the future.
At a glance
What is this study about?
When people have serious problems with their heart rhythm, a special device called an Implantable Cardioverter Defibrillator (ICD) can be implanted. This device acts like a tiny paramedic inside your body, ready to deliver a small electric shock to reset your heart if it beats dangerously fast. There are two main types, and this study focuses on the 'subcutaneous' type, or S-ICD, which sits under the skin rather than directly in the heart.
Usually, when an S-ICD is put in, doctors perform a 'defibrillation test'. This test checks that the device can deliver a shock effectively. It involves briefly putting the patient's heart into a dangerous rhythm on purpose, then letting the device correct it. While this confirms the device works, it carries some risks, such as needing general anaesthesia, prolonged recovery, or in rare cases, more serious problems like a stroke. Some previous studies have suggested that for other types of ICDs, this test might not always be necessary or improve patient outcomes much.
This study wants to see if we can safely avoid this defibrillation test for S-ICDs. Instead, we'll use a special tool called the PRAETORIAN score, which helps doctors work out the best position for the device. If we can show that putting in an S-ICD without the test is just as good and safe, it could make the procedure much easier and safer for many patients in the future, potentially reducing the need for general anaesthesia and its associated risks.
Key takeaways
- This study is about a heart device called an S-ICD for abnormal heart rhythms.
- It aims to see if an S-ICD can be safely implanted without a 'defibrillation test'.
- Avoiding this test could reduce risks and side effects from the procedure.
- A special score (PRAETORIAN) will be used to help position the device if the test is skipped.
- Participation involves either having or not having this specific test during your implant.
- You'll receive your necessary heart device regardless of study group.
Who may be eligible?
You might be able to join this study if you are an adult, aged 18 or over, who is scheduled to have a new S-ICD device implanted for the first time. You must meet the usual health guidelines for needing an ICD and pass the standard checks for an S-ICD before the study. You also need to be willing to give your agreement to take part and attend any follow-up appointments.
There are certain reasons why you wouldn't be able to join. For example, if you are pregnant, have a clot inside your heart, or have other serious health conditions that mean you aren't expected to live for more than 12 months. Also, if you have a serious heart condition called atrial fibrillation that isn't being properly treated with blood thinners, or if you're likely to need a heart transplant or another heart-assist device (LVAD) soon, you wouldn't be eligible. Your doctor will carefully check all these points.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Are you scheduled to get an S-ICD heart device for the first time?
- Are you willing and able to attend follow-up hospital visits?
- Do you have a general good health outlook for at least the next year?
- Are you not pregnant?
What does participation involve?
If you decide to join this study, you will already be scheduled to have an S-ICD device implanted. The main difference for you will be whether you have the additional 'defibrillation test' during your implant procedure or not, which will be decided randomly, like flipping a coin. You will still have your regular follow-up appointments to check your S-ICD, as you would normally, and the study will monitor how well your device works over time. The exact number and timing of these follow-up visits will be similar to what you would have anyway after an S-ICD implant. The total duration of your participation will depend on the standard follow-up schedule for your S-ICD, which typically lasts several years to monitor the device's long-term performance.
Potential risks and benefits
Locations (32)
- Adventh Health SystemVerified postcodeOrlando, United States
- Emory University HospitalVerified postcodeAtlanta, United States
- CorVita Science FoundationVerified postcodeChicago, United States
- Englewood Hospital and Medical CenterVerified postcodeEnglewood, United States
- Mount Sinai Beth IsraelVerified postcodeNew York, United States
- Icahn School of Medicine at Mount SinaïVerified postcodeNew York, United States
- Erlanger Health SystemVerified postcodeChattanooga, United States
- Asklepios KlinikenVerified postcodeHamburg, Germany
- Universitätsklinikum Schleswig-HolsteinVerified postcodeKiel, Germany
- Universitätsklinikum Schleswig-Holstein, Campus LübeckVerified postcodeLübeck, Germany
- Universitätsklinikum MannheimVerified postcodeMannheim, Germany
- Universitätsklinikum WürzburgVerified postcodeWürzburg, Germany
Common questions
What is an S-ICD?
It's a small device implanted under your skin that can deliver an electric shock to correct very fast, dangerous heart rhythms.
What is a 'defibrillation test'?
It's a test done during S-ICD implantation where doctors briefly make your heart beat irregularly to check if the device can successfully fix it.
Why might this test be avoided?
The test requires general anaesthesia and can have risks, so the study explores if it's safe to skip it using other checks.
What is the PRAETORIAN score?
It's a way doctors can check the best position for your S-ICD device to make sure it will work well, without needing the actual defibrillation test.
Will I still get my S-ICD if I join?
Yes, you will still receive your S-ICD as planned; the study is about how it's implanted, not whether you get one.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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